Oral tubes, such as endotracheal (ET) tubes, are routinely used in the practice of medicine. ET tubes, for example, typically extend into a patient's trachea in order to provide a stable airway and permit connection to a mechanical ventilation system. ET tubes can also be used in the delivery of medicines in certain circumstances. In practice, ET tubes are inserted through a patient's mouth and into the trachea to ensure that the airway is not closed off and that air is able to reach the lungs. Once placed in a patient's trachea, the ET tube must be secured in order to prevent potentially harmful movement of the tube.
Many different devices and methods have been used to secure oral tubes such as ET tubes once positioned within a patient. The most commonly employed method is simply to use an adhesive tape placed across the tube and adhering to the patient's facial skin. A review of the noted devices and methods reveals three broad categories of oral tube securing or anchoring devices. The first category involves the use of one or more straps which typically extend around a patient's head, neck, or ears. The second category, discussed briefly above, involves the use of tapes or adhesives to secure the tube, and the third category relies on a patient's teeth for fixation of the tube in position.
A seeming majority of the prior art patent literature surrounds the use of straps which are passed around the patients head, neck, or ears and are attached to a clamp to secure the tube in position. Examples of these types of devices and methods are shown in U.S. Pat. No. 3,946,742 to Eross and U.S. Pat. No. 5,490,504 to Vrona et al. which each disclose devices that utilizes a clamp and a strap to secure an ET tube. Examples of similar devices and methods which combine a strap with a tape or adhesive component are shown in U.S. Pat. No. 3,927,676 to Schultz, U.S. Pat. No. 5,306,233 to Glover, and U.S. Pat. No. 5,448,985 to Byrd. Still other examples of devices and methods which incorporate a clamp, a bite block, and a strap are shown in U.S. Pat. No. 4,351,331 to Gereg and U.S. Pat. No. 5,894,840 to King.
Although each of these exemplary devices appears effective in attaining the primary goal of securing the tube, each has its drawbacks and side effects which affect the patient. For example, devices which utilize straps can be difficult and time consuming to install and are generally uncomfortable for the patient. Even more, straps can abrade or damage the patient's skin over time. This is particularly true when straps are used in the care of burn patients whose skin has already been damaged.
Additional prior art patent literature can be found that illustrates the utilization of adhesives to secure tubes. Examples of these second category devices are illustrated in U.S. Pat. No. 3,993,081 to Cussell and U.S. Pat. No. 5,868,132 to Wintrhop et al. and each relies solely on the adherence of an adhesive to anchor the tube. Although each of these exemplary devices appears effective in attaining the primary goal of securing the tube, each has its drawbacks and side effects which affect the patient. All adhesives which are suitable for use in a medical setting, for example, have a tendency to lose adhesion over time due to degradation of the adhesive material and skin oil among other factors. Similarly, the patient can react to or be allergic to the adhesives leading to skin damage. This is particularly the case in pediatric patients who are prone to the development of adhesive tape allergies.
Last, even more patent literature can be found that illustrates the utilization of the patient's teeth to secure oral tubes. One example of such a third category device is illustrated in U.S. Pat. No. 6,675,808 to Karasic. Although the exemplary device appears effective in attaining the primary goal of securing the ET tube, it has its drawbacks and side effects which affect the patient. For example, devices which utilize the patient's teeth require that the patient have teeth. Even more, such devices can result in damage or injury to the patient's teeth.
Anchoring of nasal tubes, including nasotracheal tubes can be achieved by placing a loop of flexible material (e.g., cotton umbilical tape) around the patient's nasal septum and vomer bone as provided in U.S. Pat. No. 6,631,715 and U.S. Pat. No. 6,837,237 each issued to the present applicant. This concept allows for the securement of nasal tubes without the use of adhesive tape or the placement of straps around the patient's head, and can be accomplished in a rapid, safe, and convenient manner.
Accordingly, a need exists for a device and method capable of quickly, comfortably, and safely securing an oral tube once the tube is positioned within a patient. In addition, the apparatus would preferably not require the utilization of adhesive tapes or straps positioned around the patient's head, or rely on the patient having teeth in order to secure the tube. All of the said features are provided by the following invention. Naturally, any improvements along such lines should contemplate good engineering practices, such as simplicity, ease of implementation, unobtrusiveness, stability, etc.